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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT00262132
Date of registration:	05/12/2005
Prospective Registration:	No
Primary sponsor:	Medical University of South Carolina
Public title:	Mycophenolate for Pulmonary Sarcoidosis
Scientific title:	Mycophenolate for Pulmonary Sarcoidosis
Date of first enrolment:	September 2003
Target sample size:	20
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/show/NCT00262132
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Single Group Assignment. Masking: None (Open Label).
Phase:	Phase 3

Countries of recruitment
United States

Contacts

Name:	Don C Rockey, MD
Address:
Telephone:
Email:
Affiliation:	Medical University of South Carolina

Name:	Marc A Judson, MD
Address:
Telephone:
Email:
Affiliation:	Medical University of South Carolina

Key inclusion & exclusion criteria

Inclusion criteria:

New acute pulmonary sarcoidosis defined as a FVC or FEV1 less than 80 percent of predicted
plus symptoms of worsening dyspnea, cough, chest pain, or wheezing in patients without a
prior history of pulmonary sarcoidosis. All such patients will also require bronchoscopy
with transbronchial biopsy that demonstrates noncaseating granulomas of unknown cause. Such
patients are usually treated for acute pulmonary sarcoidosis. The transbronchial biopsy
specimens must have negative stains for mycobacteria and fungi.

> 18 years of age

Signing a written informed consent form.

Exclusion Criteria

1. Previous history of an adverse reaction to mycophenolate.

2. Current use of another immunosuppressive medication.

3. History of active hepatitis or another significant liver disease with the exception of
proven or presumed sarcoidosis of the liver.

4. Previous history of skin cancer

5. Active peptic ulcer disease

6. Pregnant and/ or lactating female

7. Serum creatinine > 2.0 mg/dl

8. Serum bilirubin > 3.0 mg/dl

9. WBC < 4,000/cu mm3

10. Has demonstrated non-compliance in the past

11. Current alcohol or drug abuse

12. Evidence of significant sarcoidosis in extrapulmonary organs that requires therapy
such that the mycophenolate doses could not be tapered if the pulmonary sarcoidosis
was stable or improved.

13. History of previous severe digestive system disease

14. Patients taking azathioprine

15. Patients taking cholestyramine or other drugs that affect enterohepatic recirculation

16. Patients with Lesch-Nyhan or Kelley-Seegmiller syndrome

17. Patients be willing not to receive live vaccines during the study

18. Patients with phenylketonuria

19. Patients with elevated serum transaminases or total bilirubin at baseline

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Sarcoidosis

Intervention(s)

Drug: Mycophenolate

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

HR 11031

CEL401

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hoffmann-La Roche

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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